Back to resultsMulticenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
Primary Purpose
Hepatic Tumor
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The Quantum Surgical device
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Tumor
Eligibility Criteria
Inclusion Criteria:
- Patient is at least 18 years old,
- Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP > 50%),
- Patient who agrees to participate in the evaluation and who has signed the inform consent,
- Patient covered by social security system.
Exclusion Criteria:
- Patient unable to undergo general anesthesia,
- Patient unable to tolerate CT contrast agent
- Patient already participating in another clinical study
- Pregnant or breast-feeding woman.
Sites / Locations
- Chu Montpellier
- Gustave Roussy Institut
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robotic device
Arm Description
Needle placement to the tumor, one time, the day of the ablation procedure
Outcomes
Primary Outcome Measures
Evaluation of the safety related to the procedure
Number of Adverse Event(s) that are considered to be major and are attributable to the needle insertion phase of the procedure
Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
Number of targets reached; the target is considered to have been reached when the needle is positioned accurately enough to allow the next step of the procedure to be carried out
Secondary Outcome Measures
Evaluation of the accuracy of the device
Assessment of the needle placement accuracy (distance from the needle tip to the target)
Evaluation of the needle readjustments of the device
Assessment of the number of needle readjustments to reach the target
Evaluation of the safety not related to the procedure
All Adverse Event(s) except those considered major and are attributable to the needle insertion phase of the procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04230642
Brief Title
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
Official Title
Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quantum Surgical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
Detailed Description
The device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of needle, as well as in verification of needle position during CT guided percutaneous ablation procedures.
After validation of the correct positioning of the needle, the tumor ablation procedure is conducted with a device routinely used by the investigator. The Acquisition of a post-interventional CT-guided image is realized to evaluate adverse events occurrence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic device
Arm Type
Experimental
Arm Description
Needle placement to the tumor, one time, the day of the ablation procedure
Intervention Type
Device
Intervention Name(s)
The Quantum Surgical device
Intervention Description
Robotic platform for needle placement
Primary Outcome Measure Information:
Title
Evaluation of the safety related to the procedure
Description
Number of Adverse Event(s) that are considered to be major and are attributable to the needle insertion phase of the procedure
Time Frame
During the procedure
Title
Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
Description
Number of targets reached; the target is considered to have been reached when the needle is positioned accurately enough to allow the next step of the procedure to be carried out
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Evaluation of the accuracy of the device
Description
Assessment of the needle placement accuracy (distance from the needle tip to the target)
Time Frame
Through study completion, an average of 1 month
Title
Evaluation of the needle readjustments of the device
Description
Assessment of the number of needle readjustments to reach the target
Time Frame
During the procedure
Title
Evaluation of the safety not related to the procedure
Description
All Adverse Event(s) except those considered major and are attributable to the needle insertion phase of the procedure
Time Frame
Through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is at least 18 years old,
Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP > 50%),
Patient who agrees to participate in the evaluation and who has signed the inform consent,
Patient covered by social security system.
Exclusion Criteria:
Patient unable to undergo general anesthesia,
Patient unable to tolerate CT contrast agent
Patient already participating in another clinical study
Pregnant or breast-feeding woman.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Guiu, MD
Organizational Affiliation
Head of radiology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Gustave Roussy Institut
City
Villejuif
ZIP/Postal Code
94000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
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